Foundation Medicine

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Charlestown, MA
Foundation Medicine

Foundation Medicine is committed to providing genomic information to help your doctor guide your care For prescription use only.

FoundationOne CDx is a qualitative genomic sequencing test for advanced cancer patients with solid tumors and analyzes 324 genes. It is intended to help doctors identify which patients may benefit from treatment with certain therapies or through clinical trials. Use of the test does not guarantee that a patient will be matched to a treatment or that all relevant genomic alterations will be detecte

d. Some patients may require a biopsy which poses certain risks. For the full product labeling, including indications for use and risk information, visit www.StartWithStepOne.com

Address

Charlestown, MA

Telephone

(888) 988-3639

Website

https://foundationmedicine.com/patient/start-with-step-one

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Intended Use Statement

Important Use and Risk Information

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The test is FDA-approved and intended to be used as a companion diagnostic to identify patients who may benefit from treatment with a specific list of targeted therapies (listed in Table 1 in the full intended use) in accordance with the approved therapeutic product labeling. Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product.

Full Product Labeling

Important Risk Information

For prescription use only.

Decisions on patient care and treatment must be based on the independent medical judgment of the treating physician, taking into consideration all applicable information concerning the patient’s condition, such as patient and family history, physical examinations, information from other diagnostic tests, and patient preferences, in accordance with the standard of care in a given community.

Use of the test does not guarantee that you will be matched to a treatment or clinical trial, or that all relevant alterations will be detected. Alterations reported may include somatic (not inherited) or germline (inherited) alterations; however, the test does not distinguish between germline and somatic alterations. The test does not provide information about susceptibility.

Biopsy may pose a risk to the patient when archival tissue is not available for use with the test. Your doctor will need to determine if you are a candidate for a biopsy. Your doctor can collect a tumor sample or past biopsy tissue can be used. Most patients with advanced cancers will already have a biopsy complete as part of initial diagnosis.

A negative result does not rule out the presence of a mutation below the limits of detection of the assay.